Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Job Summary:
HIGHRIDGE creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at HIGHRIDGE is not just work. Life at HIGHRIDGE is purpose-driven. Every day, you have the privilege of using your talents to demonstrate Confidence in your work and restore Confidence for our patients. Confidence that moves.
This person will be responsible for assisting the team with regulatory filings as necessary to market HIGHRIDGE Medical’s products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process.
Principal Duties and Responsibilities:
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.
Expected Areas of Competence (i.e., knowledge, skills, and abilities)
Education/Experience Requirements
Travel Requirements
Up to 15%
Job Type: Full-time
Pay: $61,000.00 - $81,200.00 per year
Benefits:
Experience level:
Schedule:
Ability to Relocate:
Work Location: In person
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